Table 4.
Most Common TEAEs
| Eventa | Rociletinibb (n = 75) |
Chemotherapy (n = 73) |
||
|---|---|---|---|---|
| Any Grade, n (%) | Grade ≥3, n (%) | Any Grade, n (%) | Grade ≥3, n (%) | |
| Patients with ≥1 TEAE | 74 (98.7) | 49 (65.3) | 71 (97.3) | 42 (57.5) |
| Diarrhea | 48 (64.0) | 2 (2.7) | 12 (16.4) | 1 (1.4) |
| Hyperglycemia | 44 (58.7) | 18 (24.0) | 6 (8.2) | 0 |
| Nausea | 28 (37.3) | 3 (4.0) | 20 (27.4) | 4 (5.5) |
| Fatigue | 28 (37.3) | 6 (8.0) | 18 (24.7) | 7 (9.6) |
| Decreased appetite | 28 (37.3) | 0 | 10 (13.7) | 2 (2.7) |
| Cough | 21 (28.0) | 0 | 14 (19.2) | 0 |
| QTc prolongation | 20 (26.7) | 5 (6.7) | 0 | 0 |
| Vomiting | 18 (24.0) | 1 (1.3) | 6 (8.2) | 0 |
| Anemia | 9 (12.0) | 2 (2.7) | 18 (24.7) | 2 (2.7) |
QTc, corrected QT interval; TEAE, treatment-emergent adverse event.
a
TEAEs of greater than or equal to 20% incidence in either group are illustrated, sorted by descending incidence in rociletinib-treated patients.
b
Rociletinib 500-mg twice daily and 625-mg twice-daily dosage groups were pooled for this analysis.